← FDA Drug Approvals (Drugs@FDA)
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: SPECGX LLC · Approved 2020-10-06
Drug application
- FDA Application #
ANDA213335- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE
- Generic name
- DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE
- Active ingredients
- ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- SPECGX LLC
- Manufacturer
- SpecGx LLC
- First approval
- 2020-10-06
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown